| WiSE (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S003) | EBR Systems, Inc. | 2025-10-03 |
| ProACT Adjustable Continence Therapy for Men (P130018/S004) | Uromedica, Inc. | 2025-10-03 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S938) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| Aurora EV ICD (DVEA3E4) (P220012/S058) | Medtronic, Inc. | 2025-10-03 |
| Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra (P980035/S823) | Medtronic, Inc. | 2025-10-03 |
| eCoin Tibial Nerve Stimulator System (P200036/S009) | Boston Scientific Corporation | 2025-10-02 |
| GORE® TAG® Conformable Thoracic Endoprosthesis (P040043/S146) | W. L. Gore & Associates, Inc. | 2025-10-02 |
| Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR (P980035/S825) | Medtronic, Inc. | 2025-10-02 |
| EverFlex Self-expanding Peripheral Stent System (P110023/S062) | Medtronic Vascular, Inc. | 2025-10-02 |
| Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (P980035/S822) | Medtronic, Inc. | 2025-10-02 |
| MiniMed 670G System (P160017/S129) | Medtronic Minimed, Inc. | 2025-10-02 |
| Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P200015/S070) | Edwards Lifesciences, LLC | 2025-10-02 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S056) | Medinol, Ltd. | 2025-10-02 |
| PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S026) | Edwards Lifesciences, LLC | 2025-10-02 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S210) | Boston Scientific Corp | 2025-10-02 |
| Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P140031/S193) | Edwards Lifesciences, LLC | 2025-10-02 |
| Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (P010015/S571) | Medtronic, Inc. | 2025-10-02 |
| Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV (P060011/S042) | Rayner Intraocular Lenses , Ltd. | 2025-10-01 |
| Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T (P050023/S202) | Biotronik, Inc. | 2025-10-01 |
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (P950037/S277) | Biotronik, Inc. | 2025-10-01 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T (P000009/S122) | Biotronik, Inc. | 2025-10-01 |
| Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (P980023/S138) | Biotronik, Inc. | 2025-10-01 |
| TriClip G4 Delivery System; TriClip G5 Delivery System (P230007/S017) | ABBOTT MEDICAL | 2025-09-30 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S020) | Endotronix, Inc. | 2025-09-30 |
| AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test (P150035/S032) | ABBOTT MEDICAL | 2025-09-30 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S037) | Bausch & Lomb, Inc. | 2025-09-30 |
| Plasmaflo OP-05W(A) (P820033/S017) | Asahi Kasei Medical Co., Ltd. | 2025-09-30 |
| MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S080) | ABBOTT MEDICAL | 2025-09-30 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S021) | Endotronix, Inc. | 2025-09-29 |
| AeroPace® System (P240012/S003) | Lungpacer Medical USA, Inc. | 2025-09-29 |
| LIFEPACK® CR2 Automated External Defibrillator (AED) (P170018/S024) | Physio-Control, Inc. | 2025-09-29 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S030) | Heartsine Technologies, Ltd. | 2025-09-29 |
| CentriMag Circulatory Support System (P170038/S023) | Abbott | 2025-09-29 |
| ZOLL Zenix® Monitor/Defibrillator (P160022/S036) | ZOLL Medical Corporation | 2025-09-29 |
| Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (P130008/S129) | Inspire Medical Systems | 2025-09-29 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| Nucleus® 24 Cochlear Implant System (P970051/S238) | Cochlear Americas | 2025-09-26 |
| Infinity DBS System (P140009/S122) | ABBOTT MEDICAL | 2025-09-26 |
| VenaSeal Closure System (P140018/S047) | Medtronic Vascular, Inc. | 2025-09-26 |
| Proclaim DRG System (P150004/S088) | ABBOTT MEDICAL | 2025-09-26 |
| Proclaim SCS System (P010032/S241) | ABBOTT MEDICAL | 2025-09-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S015) | ABBOTT MEDICAL | 2025-09-26 |
| Restylane® Injectable Gel (P040024/S144) | Q-Med AB | 2025-09-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour (P140029/S055) | Q-Med AB | 2025-09-26 |
| Guardant360 CDx (P200010/S021) | Guardant Health, Inc. | 2025-09-25 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S020) | Edwards Lifesciences, LLC | 2025-09-25 |
| DBS Neurostimulation System (P140009/S125) | ABBOTT MEDICAL | 2025-09-25 |
| DRG Neurostimulation System (P150004/S091) | ABBOTT MEDICAL | 2025-09-25 |
| SCS Neurostimulation System (P010032/S244) | ABBOTT MEDICAL | 2025-09-25 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| CardioMEMS HF System (P100045/S079) | ABBOTT MEDICAL | 2025-09-24 |
| AVEIR Patient Transmitter (model, LSRM01), AVEIR Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T (P150035/S028) | ABBOTT MEDICAL | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |
| FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul (P230030/S013) | Farapulse, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Shield (P230009/S008) | Guardant Health, Inc. | 2025-09-23 |
| Abre Venous Self-expanding Stent System (P200026/S014) | Medtronic Vascular, Inc. | 2025-09-23 |
| VenaSeal Closure System (P140018/S046) | Medtronic Vascular, Inc. | 2025-09-23 |
| AeroPace® System (P240012/S002) | Lungpacer Medical USA, Inc. | 2025-09-23 |
| CPR Uni-padz Electrode (P160022/S047) | ZOLL Medical Corporation | 2025-09-22 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( (P150012/S170) | Boston Scientific | 2025-09-22 |
| CPR-D-padz Electrode (P160015/S026) | ZOLL Medical Corporation | 2025-09-22 |
| Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (P030005/S248) | Guidant Corp. | 2025-09-22 |
| Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 (P010012/S595) | Boston Scientific Corp | 2025-09-22 |
| Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models (P960040/S508) | Boston Scientific | 2025-09-22 |
| Navitor Transcatheter Aortic Valve Implantation System (P190023/S027) | ABBOTT MEDICAL | 2025-09-22 |
| Accolade Non-MRI Pacemakers ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models (N970003/S302) | Boston Scientific Corp | 2025-09-22 |
| Flow Re-Direction Endoluminal Device (FRED) X System (P180027/S012) | MicroVention, Inc. | 2025-09-20 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S016) | Medtronic, Inc. | 2025-09-19 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |
| cobas HPV (P190028/S021) | Roche Molecular Systems, Inc. | 2025-09-19 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S087) | Boston Scientific Corp | 2025-09-19 |
| cobas HBV (P150014/S058) | Roche Molecular Systems, Inc. | 2025-09-19 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S043) | Boston Scientific Corp | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| OrganOx metra® System (P200035/S030) | Organox Limited | 2025-09-19 |
| TruSight Oncology Comprehensive (P230011/S005) | Illumina, Inc. | 2025-09-19 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S386) | Boston Scientific Corp | 2025-09-19 |
| Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I (P240009/S005) | Contego Medical, Inc. | 2025-09-19 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion (P860004/S450) | Medtronic, Inc. | 2025-09-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable B35200); (DBS Ne (P960009/S518) | Medtronic, Inc. | 2025-09-18 |
| IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S026) | Siemens Healthcare Diagnostics Products, Ltd. | 2025-09-18 |
| DETOUR System (P220021/S005) | Endologix, LLC | 2025-09-18 |
| IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) (P010052/S020) | Siemens Healthcare Diagnostics Products, Ltd. | 2025-09-18 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S606) | Medtronic Neuromodulation | 2025-09-18 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator 97800); (SNS Bowel Neurostimulators Impl (P080025/S330) | Medtronic Neuromodulation | 2025-09-18 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |
| RHA® Dynamic Volume, RHA®4 (P170002/S048) | Teoxane S.A. | 2025-09-18 |
| FRED X System (P180027/S014) | MicroVention, Inc. | 2025-09-18 |
| IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S025) | Siemens Healthcare Diagnostics Products, Ltd. | 2025-09-18 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S012) | ABBOTT MEDICAL | 2025-09-18 |
| ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (P140016/S015) | Cook Medical Incorporated | 2025-09-18 |
| Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le (P190018/S044) | Alcon Laboratories, LLC | 2025-09-18 |